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With Moffitt's Help, Vermillion Hoping to Demonstrate OVA1 Clinical Utility in Ovarian Cancer

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NEW YORK (GenomeWeb) – Moffitt Cancer Center is evaluating whether Vermillion's OVA1 multi-marker test can improve ovarian cancer patients' outcomes and trim unnecessary costs if it is incorporated in the continuum of care.

The Tampa, Fla.-based cancer center last week announced the launch of a two-part outcomes and economics study focused on improving ovarian cancer care and involving Vermillion's OVA1 test. In the first phase of the study, researchers led by Moffitt gynecologic oncologist Johnathan Lancaster will conduct a retrospective analysis to establish how effective the standard of care is for patients with ovarian, fallopian tube, and primary peritoneal cancers. "We will catalog the array of diagnostic and clinical events that are performed prior to the patient arriving for confirmatory surgery or definitive therapy with a gynecologic oncologist," Lancaster told PGx Reporter.

In the second phase, researchers will use predictive models to gauge how the use of Vermillion's OVA1 would have impacted the quality and cost of care. OVA1 is a US Food and Drug Administration-cleared blood test that gauges the likelihood that a woman's ovarian mass is malignant and requires surgery. The test measures the levels of five blood proteins – beta-2 microglobulin, CA 125II, apolipoprotein A1, prealbumin, and transferrin – and calculates a risk score.

In Lancaster's experience, there is plenty of opportunity to improve the care of the average ovarian cancer patient and reduce wasted expenditures. As an example, he poined out that although there is a lot of evidence showing that ovarian cancer patients have the best chance at survival if they see a gynecologic oncologist early on, fewer than half do so.

As Lancaster described it, when a woman with stomach pain or swelling comes in to see her primary care doctor or Ob/Gyn, she might get an ultrasound, where a mass is identified. At this point, the gold standard of care would be if the primary care physician sent the patient to see a gynecologic oncologist. But it's more likely that the patient would then be referred to a general Ob/Gyn for an MRI, and if that's not conclusive, sent to a gastroenterologist who would administer a colonoscopy, and so on. "And $40,000 worth of tests later, the patient still doesn't have a confirmed diagnosis, let alone undergone surgery for ovarian cancer, which is what they needed up front," Lancaster said.

For the first part of the outcomes and cost study on OVA1, Lancaster and his colleagues will use Moffitt's clinicogenomic database which contains clinical and molecular data on up to 300,000 patients. In this database, researchers can follow and re-contact for additional research 100,000 patients. "We posed the question: why don't we go back into this research database, identify those patients who have a diagnosis of ovarian cancer, but for whom there was an array of clinical interventions performed prior to them arriving at the door of a gynecologic oncologist?" Lancaster said.

After assessing the baseline patient outcomes and costs associated with ovarian cancer treatment, Moffitt researchers will assess in the second phase of the study the proportion of patients that would have been more quickly referred to a gynecologic oncologist based on the risk assessment from OVA1; how many would have still been referred to other types of doctors and gotten additional tests; and how many would have been found to be at low risk, ruled out for surgery, and sent to a regular gynecologist.

Lancaster is in a unique position to lead the outcomes and cost study on OVA1, since at Moffitt he is simultaneously focused on improving ovarian cancer patients outcomes using molecular strategies and reducing the cost of care. At the cancer center, Lancaster runs a translational research lab investigating the molecular underpinnings of ovarian cancer and is president of the Moffitt Medical Group, where he negotiates value-based contracts and alternative payment models with payors.

"When we began to talk to Vermillion about their biomarker program, the initial discussion was very much on the first part of my life, which is biomarker discovery, development, and validation. The discussion was very much about sensitivity and specificity [of the test] … [and] the data is pretty sound on that," Lancaster said.

"As the conversation evolved it appeared there was very much another aspect to this," he continued. "And with the other side of my brain engaged, I started to think about it from the perspective of quality, value, cost-effectiveness, and the opportunity to really make a difference in how patients are managed, not just from a survival perspective but also from a value-based perspective."

Each year in the US, approximately 22,000 women are diagnosed with ovarian cancer and more than 14,000 die from the disease. The latest tools and treatments for ovarian cancer have had a limited impact on patients' survival, with the five-year survival rate improving from 33.6 percent in 1975 to 44 percent currently. The inability to effectively implement early diagnosis and treatment strategies for ovarian cancer patients is major factor for why their survival has not robustly improved over the years.

Vermillion believes that its test can improve outcomes for ovarian cancer patients but the firm has struggled to convince payors about the value of OVA1, which in turn has held back test adoption. For example, Aetna last month issued a clinical policy bulletin in which it named OVA1 among a list of "experimental and investigational" tests that are not covered. BlueCross BlueShield made a similar non-coverage determination in 2013. Meanwhile, CMS decided to crosswalk the pricing for OVA1, a decision Vermillion's leadership saw as unfavorable for OVA1 pricing. In 2013, doctors performed 17,004 OVA1 tests, up only 3 percent from 16,460 tests performed in 2012.

As of last year, the company has been working to terminate certain terms of a deal with Quest Diagnostics that placed the reference lab in charge of commercializing OVA1. After Quest sales reps failed to drive adoption of the test to Vermillion's satisfaction, the company reestablished control over test commercialization and announced a "tactical US commercial relaunch of OVA1." Now, Vermillion is planning to bolster its sales force behind the test; spruce up educational events for doctors; and increase commercialization efforts at hospitals. The company recently launched a new clinical reference lab that gives Vermillion the capability to run OVA1 in house.

The clinical utility study with Moffitt likely falls into Vermillion's broader relaunch strategy for OVA1. Over the years, Vermillion has worked to build up the evidence base for the test. The performance of OVA1 has been investigated in four studies published in peer-reviewed journals. A March paper in the American Journal of Obstetrics & Gynecology reported, for example, that OVA1 combined with imaging could reduce the number of ovarian cancers compared to when doctors used imaging alone.

In order to drive adoption of a molecular diagnostic, it's no longer enough to show the test is performing as it should, Lancaster reflected. Payors are demanding test developers show how their diagnostic impacts patients' health and importantly, as well as how the test fits in to the cost of treating patients during the course of their disease.

"In order to launch and sustain any kind of biomarker assay you simply needed to show that it predicts what you thought it predicted and you validate it. … and that was sufficient and you could put a $3,500 tag on it and sell it," he said. "It's become imperative as we enter this world of value that that's only part of it. That only gets you in the game but really for these sorts of personalized medicine tools to become part and parcel of day-to-day medicine in the future, you're going to need to demonstrate … that not only does it benefit patients but that it does so in a cost-effective manner."

The study is being funded through an unrestricted grant from molecular diagnostics firm Vermillion. Lancaster would not reveal how much money had been dedicated to the study to date.

He noted, however, that there is no conflict of interest in Moffitt doing this cost and outcomes study for OVA1, since a cancer center wouldn't have much use for such a test. "By the time they get to a cancer center they've been diagnosed with ovarian cancer or some form of malignancy. The opportunity to sell their product is outside of the doors of this building," he said. "If they came to us and said, 'Hey do you want to use our test?' we'd say no because by the time they've come to us they're already diagnosed or have such a high suspicion and probability of a malignancy that they're going to an operating table anyway."

OVA1 would ideally come in to the picture when a patient visits her Ob/Gyn with stomach pain and an ultrasound reveals some kind of mass. This is the point at which the Ob/Gyn must decide whether to send the patient to a gynecologic oncologist or prescribe some lesser intervention. "That's the scenario where [OVA1] could be of greatest value," Lancaster said.

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